Model Number 2420-0007 |
Device Problem
Stretched (1601)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
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Event Description
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It was reported that the primary tubing is "bubbling" and the walls seem thin.There was no patient harm reported.
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Manufacturer Narrative
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Correction; (patient code).The customer¿s report that the primary tubing is "bubbling" and the walls seem thin was confirmed.The as-received set samples were visually inspected for kinks, incomplete bonding, holes/tears in the tubing or damages to the components.During inspection of the set sample it was observed that there was a bulge along the silicone segment.Further handling of the observed bulge area noted it felt softer/weaker as compared to the rest of the silicone segment.No other issues were observed with the set sample and no issues of concentricity with the silicone segment were observed.Previously investigated complaints for this failure mode determined that the bulge is caused by excess pressure within the silicone segment.The root cause for the source of the excessive pressure is unknown.
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Event Description
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It was reported that the primary tubing is "bubbling" and the walls seem thin.It has been confirmed through follow up, that there was no patient harm as a result of this event.
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Search Alerts/Recalls
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